CancerNCT05054569
Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors
A study testing Cognitive-Behavioral Stress Management and Health Education in people with Cancer, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to develop and pre-test an eHealth group intervention for young adult cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- Cognitive-Behavioral Stress Management and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-39 years at the time of participation
- diagnosed with a non-metastatic primary cancer between 18-39 years old
- completed primary cancer treatment (excepting hormone therapy) 1 month to 5 years prior to enrollment
- able to speak and read English
- access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences
Who cannot join
- metastatic disease
- psychiatric or neurological disorders that could interfere with study participation
- considered part of a vulnerable population
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
The purpose of this study is to develop and pre-test an eHealth group intervention for young adult cancer survivors.
Read the detailed description
In the first part of this study, the investigators adapted an evidence-based intervention for improving HRQOL to better meet the needs of young adult cancer survivors, and then conducted focus groups with young adult cancer survivors to get feedback on the adapted intervention. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the adapted intervention will be delivered over videoconference via weekly group meetings with a trained facilitator over the course of 10 weeks.
- Conditions
- Cancer
- Being tested
- Cognitive-Behavioral Stress Management and Health Education
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Stress Management and Health EducationBehavioural
Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.
| Study group | Role | What they receive |
|---|---|---|
| 10-week eHealth intervention | Experimental | Weekly video conference groups led by a trained facilitator Receives: Behavioral: Cognitive-Behavioral Stress Management and Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the adapted intervention
Participants will report their satisfaction with individual sessions through brief weekly surveys.
Measured: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
Acceptability of the adapted intervention
The number of sessions attended, out of a maximum of 10, will be tracked.
Measured: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
Acceptability of the adapted intervention
Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.
Measured: Immediately after the intervention
Secondary outcomes (5)
Change in health-related quality of life (HRQOL) from baseline to immediately after the intervention
Participants will complete the 27-item Functional Assessment of Cancer Therapy - General. Scores range from 0 to 108, with higher scores reflecting better quality of life.
Measured: Baseline and immediately after the intervention
Change in symptom burden from baseline to immediately after the intervention
Participants will complete a modified version of the Edmonton Symptom Assessment Scale, which assesses 10 common cancer-related symptoms each on a numerical rating scale ranging from 0 to 10. Higher scores indicate greater symptom burden.
Measured: Baseline and immediately after the intervention
Change in cancer-related distress from baseline to immediately after the intervention
Participants will complete the 22-item Impact of Event Scale-Revised. Scores range from 0 to 88, with higher scores indicating greater cancer-related distress.
Measured: Baseline and immediately after the intervention
Change in stress management skills self-efficacy from baseline to immediately after the intervention
Participants will complete subscales from the Measure of Current Status. Subscale scores range from 0 to 8, 0 to 12, or 0 to 20 depending on the subscale. Higher scores indicate more of the construct being assessed.
Measured: Baseline and immediately after the intervention
Change in coping from baseline to immediately after the intervention
Participants will complete the Brief Coping Orientation to Problems Experienced scale, which yields 14 two-item subscales. Subscale scores range from 2 to 8, with higher scores indicating greater usage of the coping strategy being assessed.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Sep 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Rina Fox, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054569
- Sponsor's protocol ID
- NU 20CC18
- Other IDs
- IRG-18-163-24, STU00214055
- Status last verified
- Dec 2021
- First submitted
- 3 Sep 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fox RS, Badger TA, Moya S, Gudenkauf LM, Nelson MA, O'Neill RM, Leete JJ, Friedman SE, Katsanis E, Victorson DE, Sanford SD, Penedo FJ, Antoni MH, Oswald LB. An HRQOL Proof-Of-Concept Analysis of the eHealth TOGETHER Intervention for Adolescent and Young Adult Cancer Survivors: A Brief Report. Psychooncology. 2025 Jul;34(7):e70234. doi: 10.1002/pon.70234.
PubMed 40879639Oswald LB, Lyleroehr M, Gudenkauf LM, Armstrong GE, Tometich DB, Sanford SD, Loecher N, Geiss C, Rodriguez Y, Scheel KL, Nieves-Lopez A, Jim HSL, Gonzalez BD, Antoni MH, Penedo FJ, Reed D, Katsanis E, Salsman JM, Victorson D, Fox RS. Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors. Support Care Cancer. 2022 Dec;30(12):10067-10076. doi: 10.1007/s00520-022-07382-y. Epub 2022 Oct 14.
PubMed 36229547
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05054569
- Acronym / sponsor ID
- NU 20CC18
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and pre-test an eHealth group intervention for young adult cancer survivors.
Detailed description
In the first part of this study, the investigators adapted an evidence-based intervention for improving HRQOL to better meet the needs of young adult cancer survivors, and then conducted focus groups with young adult cancer survivors to get feedback on the adapted intervention. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the adapted intervention will be delivered over videoconference via weekly group meetings with a trained facilitator over the course of 10 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10-week eHealth intervention | Experimental | Behavioral: Cognitive-Behavioral Stress Management and Health EducationWeekly video conference groups led by a trained facilitator |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 18-39 years at the time of participation
- diagnosed with a non-metastatic primary cancer between 18-39 years old
- completed primary cancer treatment (excepting hormone therapy) 1 month to 5 years prior to enrollment
- able to speak and read English
- access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences
Key exclusion criteria (3 listed)
- metastatic disease
- psychiatric or neurological disorders that could interfere with study participation
- considered part of a vulnerable population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Stress Management and Health EducationParticipants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content. | Behavioural | 10-week eHealth intervention |
Primary outcome
Acceptability of the adapted intervention
Time frame: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
Participants will report their satisfaction with individual sessions through brief weekly surveys.
Acceptability of the adapted intervention
Time frame: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
The number of sessions attended, out of a maximum of 10, will be tracked.
Acceptability of the adapted intervention
Time frame: Immediately after the intervention
Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.
5 secondary outcomes
Change in health-related quality of life (HRQOL) from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in symptom burden from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in cancer-related distress from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in stress management skills self-efficacy from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in coping from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 40879639Fox RS, Badger TA, Moya S, Gudenkauf LM, Nelson MA, O'Neill RM, Leete JJ, Friedman SE, Katsanis E, Victorson DE, Sanford SD, Penedo FJ, Antoni MH, Oswald LB. An HRQOL Proof-Of-Concept Analysis of the eHealth TOGETHER Intervention for Adolescent and Young Adult Cancer Survivors: A Brief Report. Psychooncology. 2025 Jul;34(7):e70234. doi: 10.1002/pon.70234.
- Derived from this study: PubMed 36229547Oswald LB, Lyleroehr M, Gudenkauf LM, Armstrong GE, Tometich DB, Sanford SD, Loecher N, Geiss C, Rodriguez Y, Scheel KL, Nieves-Lopez A, Jim HSL, Gonzalez BD, Antoni MH, Penedo FJ, Reed D, Katsanis E, Salsman JM, Victorson D, Fox RS. Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors. Support Care Cancer. 2022 Dec;30(12):10067-10076. doi: 10.1007/s00520-022-07382-y. Epub 2022 Oct 14.
- Individual participant dataSharing planned: No
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Stress Management and Health Education in people with Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the adapted intervention (time frame: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054569, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.